Abstract
BACKGROUND: Evidence supports the long-term efficacy of Nucleos(t)ide Analogs (NAs) therapy in improving chronic hepatitis B (CHB) prognosis. However, determining the most cost-effective first-line NAs remains unclear. China's implementation of the New Volume-Based Procurement Policy (NVBP Policy) in 2019 led to substantial price reductions for entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF). This study assesses the cost-effectiveness of ETV, TDF, and TAF, both with and without NVBP, for CHB in China. METHODS: A state-transition model, parameterized using data from published literature, was utilized to compare treatment strategies encompassing non-NAs best support care (BSC), ETV, TDF, and TAF, with or without NVBP. A simulated lifetime cohort was employed, measuring outcomes such as predicted liver-related deaths, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: In comparison to Non-NAs BSC, TAF yielded an additional 2.68 QALYs per person, with an ICER of 7,853.22 USD/QALY. Subsequently, TDF generated an additional 2.61 QALYs/person at an ICER of 7,153.39 USD/QALY, and ETV produced an additional 2.01 QALYs/person with an ICER of 9,366.74 USD/QALY without NVBP. Incorporating NVBP, the ICERs for TAF, TDF, and ETV decreased to -745.62 USD/QALY, -729.33 USD/QALY, and -871.11 USD/QALY, respectively, compared to non-NAs BSC. At willingness-to-pay (WTP) thresholds ranging from 12,500 USD/QALY to 37,500 USD/QALY, TAF with NVBP showed an increased probability (51.15-52.47%) of being the optimal treatment strategy, followed by TDF and ETV with NVBP exhibiting a reduced likelihood 43.09-42.45% and 6.40-4.48% in the iterations. CONCLUSIONS: Our analysis suggests that TAF with NVBP represents the most cost-effective long-term therapy for CHB. Both TDF and ETV, with or without NVBP, and TAF without NVBP were considered cost-ineffective.